基于化学识别模式的金花三宝口服液HPLC指纹图谱及多成分含量测定研究

Based on chemical identification mode of HPLC fingerprint and multi-component content determination of Jinhua Sanbao oral liquid

基于化学识别模式,建立HPLC指纹图谱及多成分含量测定,为金花三宝口服液的质量评价提供参考。采用HPLC法,以Capcell Pak C_(18)(250mm×4.6mm,5μm)为色谱柱,流速为0.8mL·min^(-1),流动相是甲醇(A)-0.1%磷酸水(B),柱温为30℃,进样量为10μL,检测波长为266nm;建立指纹图谱并同时测定6个成分的含量,采用聚类分析(CA),主成分分析(PCA)以及偏最小二乘-判别分析(PLS-DA)对数据进行分析。指纹图谱共确定了13个共有峰,并指认了6个成分;相似度值为0.958以上;聚类分析,主成分分析将样品划分为2类,偏最小二乘-判别分析筛选出峰12,新绿原酸,芦丁等8个质量差异标志成分。含量测定结果表明:10批金花三宝口服液中新绿原酸、绿原酸、隐绿原酸、异绿原酸A、芦丁、异绿原酸C的平均含量依次为:0.2183,0.8465,0.1644,0.3790,0.0749,0.1701mg·mL^(-1)。本研究所建立的HPLC指纹图谱及多成分的含量测定准确,稳定可行,可为质量控制提供参考依据。

Based on the chemical identification mode,the HPLC fingerprints and multi-component content determination were estab-lished,which provided reference for the quality evaluation of Jinhua Sanbao oral liquid.Using HPLC method with Capcell Pak C_(18)(250mm×4.6mm,5μm)as the column,flow rate was 0.8 mL·min^(-1),mobile phase was methanol(A)-0.1%water(B),column tem-perature was 30℃,sample intake was 10 uL,detection wavelength was 266nm.It was established by HPLC fingerprint and determined the content of the six components simultaneously;and data was analyzed by similarity evaluation,cluster analysis,principal component analysis and partial minimum discrimination method.13 Common peaks were identified in the fingerprint map of Jinhua Sanbao oral liquid,and was identified 6 components.The similarity value was above 0.958,and the samples were divided into 2 classes by cluster analysis and principal component analysis.Eight quality difference markers were selected by partial minimum two discrimination law including peak 12,new chlorogenic acid and rutin.The results showed that the mean content of new chlorogenic acid,chlorogenic acid A,cryptochlorogenic C acid,rutin in 10 batches of Jinhua Sanbao oral liquid were 0.2183,0.8465,0.1644,0.3790,0.0749,0.1701 mg·mL^(-2).The HPLC fingerprints were accurate,stable and feasible,and could provide reference for quality control.